Antiviral Drugs on the Treatment of SARS-CoV-2 | NCT04727775

Studies
Antiviral Drugs on the Treatment of SARS-CoV-2

NCT04727775

Sponsor

Astana Medical University

Status

Completed

Last Update Posted

Aug 2, 2023Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Complication of Medical Care
Pneumonia, Viral

Interventions

Favipiravir
Remdesivir

Countries

Kazakhstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Jul 25, 2023Actual

Completion Date

Jul 25, 2023Actual

First Submitted Date

Jan 22, 2021

First Submission Date that Met QC Criteria

Jan 25, 2021

First Posted Date

Jan 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2023

Last Update Posted Date

Aug 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases

Detailed Description

Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Complications	Evaluathion	Drug: Favipiravir Drug: Remdesivir
Oxygen status	Evaluathion	Drug: Favipiravir Drug: Remdesivir
Oxugen support	Evaluathion	Drug: Favipiravir Drug: Remdesivir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Favipiravir	Drug	Antiviral drugs	Complications Oxugen support Oxygen status

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Outcome without comlications	The recovery time will be evaluated with and without antiviral drugs retrospectively in homogeneous groups of patients with SARS-CoV2	14 days

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Measure	14 days
SpO2	Measure	14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

main group

Patients with COVID19 with medium and easy condition disease
take favipiravir/remdisivir control group
Patients with COVID19 with medium and easy condition disease
not take favipiravir/remdisivir

Exclusion Criteria:

patients younger 18
severe conditionis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with previous covid 19 pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aidos Konkaev		Astana		010000	Kazakhstan
Semey Medical University

IPD Sharing Statement Module

Plan to Share IPD

Description

Retrospective study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011024	Pneumonia, Viral

Ancestor Terms

ID	Term
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C462182	favipiravir
C000606551	remdesivir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided